Consumer medicine information

Chlorhexidine Irrigation Solution

Chlorhexidine gluconate

BRAND INFORMATION

Brand name

Bridgewest Chlorhexidine Irrigation Solution

Active ingredient

Chlorhexidine gluconate

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Chlorhexidine Irrigation Solution.

SUMMARY CMI

Chlorhexidine Irrigation Solution

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using Chlorhexidine Irrigation Solution?

Chlorhexidine Irrigation Solution contains the active ingredient chlorhexidine gluconate.

Chlorhexidine Irrigation Solution is used for cleansing and irrigating the skin or wounds, or to prepare your body before using a special tube to drain the bladder (catheter). For more information, see Section 1. Why am I using Chlorhexidine Irrigation Solution? in the full CMI.

2. What should I know before I use Chlorhexidine Irrigation Solution?

Do not use if you have ever had an allergic reaction to Chlorhexidine Irrigation Solution or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use Chlorhexidine Irrigation Solution? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Chlorhexidine Irrigation Solution and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How Chlorhexidine Irrigation Solution is used?

Your doctor or nurse will normally use the irrigation solution to wash and clean your skin or wounds, or to clean your genital area before a special tube called a catheter is used to drain your bladder. It is for external use only and should not be injected or swallowed. It should not be used in the eyes or ears or as enema.

More instructions can be found in Section 4. How do I use Chlorhexidine Irrigation Solution? in the full CMI.

5. What should I know while using Chlorhexidine Irrigation Solution?

Things you should do
  • If you are given this product to use at home, it must be used as directed by your doctor or nurse.
  • Discard any unused portion. Chlorhexidine Irrigation Solution is for single use only.
  • Tell your doctor, nurse or pharmacist as soon as possible if you feel anything unusual during or after Chlorhexidine Irrigation Solution has been used.
Looking after your medicine
  • Store below 25°C and protect from light.

For more information, see Section 5. What should I know while using Chlorhexidine Irrigation Solution? in the full CMI.

6. Are there any side effects?

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.



FULL CMI

Chlorhexidine Irrigation Solution

Active ingredient(s): chlorhexidine gluconate


Consumer Medicine Information (CMI)

This leaflet provides important information about using Chlorhexidine Irrigation Solution. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Chlorhexidine Irrigation Solution.

Where to find information in this leaflet:

1. Why am I using Chlorhexidine Irrigation Solution?
2. What should I know before I use Chlorhexidine Irrigation Solution?
3. What if I am taking other medicines?
4. How Chlorhexidine Irrigation Solution is used?
5. What should I know while using Chlorhexidine Irrigation Solution?
6. Are there any side effects?
7. Product details

1. Why am I using Chlorhexidine Irrigation Solution?

Chlorhexidine Irrigation Solution contains the active ingredient chlorhexidine gluconate. Chlorhexidine Irrigation Solution is an antiseptic that will help prevent infection.

Chlorhexidine Irrigation Solution is used for cleansing and irrigating the skin or wounds, or to prepare your body before using a special tube to drain the bladder (catheter).

2. What should I know before I use Chlorhexidine Irrigation Solution?

Warnings

Do not use Chlorhexidine Irrigation Solution:

  • if you are allergic to chlorhexidine, or to any of the ingredients listed at the end of this leaflet.
    Always check the ingredients to make sure you can use this medicine.
  • to irrigate eyes or ears, or as enema.
  • as skin preparation for face or head before operation.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Chlorhexidine Irrigation Solution.

4. How Chlorhexidine Irrigation Solution is used?

How much to use

Your doctor or nurse will decide how much of the irrigation solution to use which will be sufficient for your needs.

As the irrigation solution is sterile, your doctor or nurse will use a new solution each time.

How to use Chlorhexidine Irrigation Solution

  • Your doctor or nurse will normally use the irrigation solution to wash and clean your skin or wounds, or to clean your genital area before a special tube called a catheter is used to drain your bladder.
  • It is for external irrigation use only and should not be injected or swallowed.
  • It should not be used in the eyes or ears.
  • If you are given this product to use at home, it must be used as directed by your doctor or nurse.
    - Rinse the area to be cleaned with water, then use the smallest amount of irrigation to gently wash the area.
    - Rinse again with water thoroughly.
    - Use a new solution each time.

If you use too much Chlorhexidine Irrigation Solution

As your doctor or nurse will administer this irrigation, they will use the correct amount. As it is for external use only, it is unlikely an overdose will occur.

If you think that someone may have swallowed Chlorhexidine Irrigation Solution or if it has been put into the eyes or ears, you should immediately:

  • phone the Poisons Information Centre
    (by calling 13 11 26), or
  • contact your doctor, or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using Chlorhexidine Irrigation Solution?

Things you should do

  • If you are given this product to use at home, it must be used as directed by your doctor or nurse.
  • Discard any unused portion. Chlorhexidine Irrigation Solution is for single use only.

Call your doctor straight away if you:

  • Develop any allergic or hypersensitivity reactions or anaphylaxis to Chlorhexidine Irrigation Solution.

Things you should not do

  • Do not use in the eyes or ears or as enema.
  • Do not swallow or inject into your body.

Looking after your medicine

  • Store below 25°C and protect from light.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

  • in the bathroom or near a sink, or
  • in the car or on window sills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor, nurse or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effectsWhat to do
  • Skin rash or irritation
  • blood in the urine
Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effectsWhat to do
  • hypersensitivity/allergic reactions or anaphylaxis
Symptoms may include shortness of breath, wheezing or difficulty in breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin.
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor, nurse or pharmacist if you notice anything else that may be making you feel unwell during or after Chlorhexidine Irrigation Solution has been used.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor, nurse or pharmacist before you decide to stop taking any of your medicines.

7. Product details

What Chlorhexidine Irrigation Solution contains

Active ingredient
(main ingredient)
  • Chlorhexidine gluconate
Other ingredients
(inactive ingredients)
  • Methylene blue
  • Octoxinol 8
    (Chlorhexidine 0.1% w/v only)
  • Gluconic acid
  • Sodium hydroxide
  • Water for injections

Tell your doctor or nurse if you are allergic to any of these ingredients.

What Chlorhexidine Irrigation Solution looks like

Chlorhexidine Irrigation Solution is a sterile, blue solution and comes in a 30 mL plastic ampoule in packs of 30 units.

Chlorhexidine 0.1% Irrigation Solution ampoule (AUST R 11175)

Chlorhexidine 0.2% Catheter Preparation Irrigation Solution ampoules (AUST R 11324)

* Not all presentations may be marketed.

Who distributes Chlorhexidine Irrigation Solution

Bridgewest Perth Pharma Pty Ltd
15 Brodie Hall Drive
Bentley WA 6102
Telephone: 1800 161 156
[email protected]

This leaflet was prepared in September 2023.

Published by MIMS November 2023

BRAND INFORMATION

Brand name

Bridgewest Chlorhexidine Irrigation Solution

Active ingredient

Chlorhexidine gluconate

Schedule

Unscheduled

 

1 Name of Medicine

Chlorhexidine gluconate.

2 Qualitative and Quantitative Composition

Chlorhexidine gluconate 30 mg/30 mL (0.1% w/v).
Chlorhexidine gluconate 60 mg/30 mL (0.2% w/v).

3 Pharmaceutical Form

Sterile blue coloured irrigation solution containing chlorhexidine gluconate in water for injections. The colouring agent is methylene blue. Chlorhexidine Irrigation Solution 0.1% w/v contains nonoxynol 8 as a wetting agent.

4 Clinical Particulars

4.1 Therapeutic Indications

Chlorhexidine Irrigation Solution 0.1% w/v.

For skin and wound irrigation or dressing to prevent and control infection.

Chlorhexidine Irrigation Solution 0.2% w/v.

For antisepsis of external genitalia prior to catheterisation of the bladder.

4.2 Dose and Method of Administration

Chlorhexidine Irrigation Solution 0.1% w/v.

Rinse the area to be cleaned with water, apply the minimum amount of irrigation necessary to cover the wound area and wash gently. Rinse again thoroughly. Apply to wound as necessary. Discard remaining solution after use.

Chlorhexidine Irrigation Solution 0.2% w/v.

Irrigate the area of the external genitalia thoroughly prior to catheterisation.

4.3 Contraindications

Known hypersensitivity to chlorhexidine.
Do not use to irrigate the brain, meninges, eyes or perforated eardrums.
Do not use in body cavities or as enema.

4.4 Special Warnings and Precautions for Use

For external use only. Not for injection, for irrigation only. Not isotonic and is haemolytic.
Not to be used as a preoperative skin preparation for face or head.

Use in the elderly.

No data available.

Paediatric use.

Use with care in neonates, particularly in premature infants. Chlorhexidine may cause irritation or chemical burns.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No data available.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category A)
Chlorhexidine has been used by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.
Based on negligible topical absorption and a complete lack of any unusual reported effects when used during pregnancy, chlorhexidine would not appear to present a risk to pregnant women. No special precautions or changes in methods of application or use of chlorhexidine seem needed in pregnant healthcare workers or patients.
No data available.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Irritative skin reactions and hypersensitivity reactions to chlorhexidine have been reported. In the event that these reactions occur, discontinue use.
Chlorhexidine may cause anaphylaxis.
Haematuria has been reported following bladder irrigation.
There have been at least four cases of irreversible corneal damage due to contact with chlorhexidine. Chlorhexidine has been reported to cause deafness when instilled into the middle ear through a perforated eardrum.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

Symptoms and treatment.

In case of accidental or deliberate oral poisoning or ingestion.

Chlorhexidine taken orally is poorly absorbed. Immediate dilution with (120-240 mL) water or milk (not to exceed 15 mL/kg in children) is recommended. The administration of charcoal is not likely to be beneficial and may obscure visualisation during endoscopy. It is not recommended unless other substances known to be absorbed to charcoal are co-ingested. Employ supportive measures as appropriate.

In case of accidental intravenous administration.

Haemolysis due to hypotonicity has been reported. Blood transfusion may be necessary to counteract haemolysis.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Chlorhexidine is an antiseptic and disinfectant which is effective against a wide range of vegetative Gram positive and Gram negative organisms, some viruses and some fungi. It is ineffective against bacterial spores at room temperature, and acid fast bacteria are inhibited but not killed. It is more active against Gram positive than Gram negative bacteria and some species of Pseudomonas and Proteus are relatively less susceptible. Chlorhexidine is most active at a neutral or slightly acid pH and its activity may be reduced by blood and other organic matter.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

No data available.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

Chlorhexidine is not teratogenic in rats.

6 Pharmaceutical Particulars

6.1 List of Excipients

Chlorhexidine Irrigation Solution 0.1% w/v: gluconic acid, methylene blue, nonoxinol 8, sodium hydroxide, water for injections.
Chlorhexidine Irrigation Solution 0.2% w/v: gluconic acid, methylene blue, sodium hydroxide, water for injections.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C. Protect from light. Single use only. Discard unused portion.

6.5 Nature and Contents of Container

Chlorhexidine 0.1% irrigation solution, 30 mL (sterile) LDPE ampoule.
Chlorhexidine 0.2% irrigation solution, 30 mL (sterile) LDPE ampoule.
Pack size: 30 units.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chlorhexidine gluconate solution is an almost colourless or pale yellowish liquid. It is miscible with water, soluble in acetone and in alcohol. The structural formula of chlorhexidine gluconate is represented:

Chemical structure.


Molecular Formula: C22H30Cl2N10,2C6H12O7.
Molecular Weight: 898.

CAS number.

18472-51-0.

7 Medicine Schedule (Poisons Standard)

Not scheduled.

Summary Table of Changes